Field of the Invention
The invention relates to the field of monitoring the integrity of pharmaceutical products that are sensitive to physical or environmental conditions. More specifically, it relates to the monitoring of the integrity of a pharmaceutical product in a vial. The invention relates to ways of estimating the integrity of a pharmaceutical product in a vial as assessed from the exposure of the product to physical or environmental conditions up to at least approximately the time of its use.
Description of Related Art
The invention relates to articles or devices that find application, e.g., when a patient taking a medicament or a health care specialist giving the medicament to the patients wants to make sure that the medicament has not perished, in particular not perished during the time span between packaging the medicament and applying the medicament.
When it comes to sensitive or delicate pharmaceutical products, it can be desirable to monitor their exposure to specific hazards such as particularly high or low temperatures, particularly high or low humidity (water-content of ambient air), or particularly strong impacts (hits, blows), so as to be able to estimate the integrity of the transported or stored goods.
It is known to use chemical indicators for estimating the temperature exposure of a medicament. For example, a particular chemical substance is applied onto a vial containing a pharmaceutical product. If that substance is exposed to a too high or too low temperature during a too long time, its color is (visibly) changed. Corresponding products are commercially available.
Furthermore, RFID tags are frequently used by transport and logistics companies for monitoring the integrity of various goods during their transport from the manufacturer of the goods to a distributor or wholesaler. Such RFID tags are, e.g., attached to a trading unit on a palette, and results of measurements carried out in the RFID tag, e.g., temperature measurements, are wirelessly transmitted to the RFID reader in order to be evaluated and/or looked at then.